Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
FAQs
U.S. Commercial Service Contact Information
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Executive Summary
The United States and Guatemala enjoy a strong and growing trade relationship, especially under the U.S.-Central America-Dominican Republic Free Trade Agreement (CAFTA-DR). The United States is Guatemala’s largest trading partner, accounting for nearly 40% of Guatemala’s trade.
Guatemala is a country of over 17.5 million citizensinhabitants. The country has high levels of poverty; many people require assistance fromby the public sector for their health care needs, though many inhabitants do not use public services because they can afford a private hospital or clinic. The market of medical services is divided between the private and public sectors.
The private sector, as a common rule, purchases only well-known brands of medical equipment because of their appreciation for high quality products and total customer support from the distributor in any emergency. Investments in new medical equipment within the private healthcare sector are expected to continue, as new clinics and current hospitals buy periodically to meet their equipment needs and continue to invest strongly in new technology, such as diagnostic and treatment equipment.
The government, on the other side, is price-driven and will purchase from the lowest bidder via public tenders. All medical services in public hospitals and clinics are free of charge to any patient. This means major hospitals are replacing older equipment and buying new equipment that can meet the demand of free medical services for the population. The public sector consists of hospitals and clinics operated by the Ministry of Health through the Social Security Institute and the armed forces.
Despite the economic difficulties faced by each country in the region, demand in this sector has not diminished, as 60% of service users have private medical insurance.
Experts expect a growth in demand for services in the private sector. Hospitals will continue to increase up to 12% for 2022, and this growth will likely continue because health is a priority service for the population.
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Market Entry
The most important decision a U.S. company should make is to choose a local representative. The best strategy is to screen potential importer-distributors and select the most qualified.
The chosen importer should be a company that is registered to sell to the government and can participate in official tenders and bids. Also, the company needs to know the private market and have constant communication with the purchase managers of hospitals, clinics, and medical doctors with practices that use relevant equipment.
Once exclusive representation is given to a Guatemalan importer, it is difficult to take it back because of the representation law in Guatemala; therefore, it is necessary to have a good relationship and choose the correct representative. The legal system can be slow and the law, under certain conditions, offers local agents a great deal of protection.
Formal agency or distribution agreements should be reviewed by a Guatemalan attorney hired by the U.S. exporter (independent of the Guatemalan party with which the agreement is being established).
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Current Market Trends
Preferences of Local Consumers
The preferences of hospitals and clinics for medical equipment are based mostly on:
Brand name
Specifications of the equipment
After sales and training of the end user
Latest technology or world trends
Demand of Differentiated Market
The final consumers or end users of the medical equipment are the private and public hospitals and clinics in Guatemala. The difference between these markets is that private customers buy immediately and often look for the best brand of equipment; meanwhile, public purchases are made by bids all year long and are announced by the government via the website for government procurement (www.guatecompras.gt ).
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Best Prospects
Healthcare is not a best prospect for Guatemala.
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Market Size
Healthcare spending (including investment)
Data Not available
… as percent of GDP
Data Not available
… of which spent on inpatient services (including long-term care)
Data Not available
… of which spent on pharmaceuticals/consumables
Data Not available
… of which spent on investments
Data Not available
… of which spent on outpatient services
Data Not available
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
…Public
150 + 2,500 clinics
…Private
45
Number of hospital beds
Data Not Available
… available beds per capita
…of which in general hospitals
…of which in specialized clinics and rehabilitation centers
Number of surgical procedures
1,533
…of which [top procedure]
N/A
…of which [second highest procedure]
N/A
Physicians
0.9 Physicians / 1,000 population
…of which surgeons
N/A
…of which internists
N/A
…of which pediatricians
N/A
Dentists
N/A
Demographics
Population
17 million
Life expectancy men/women
69.4 / 76.00
Infant mortality
22 deaths / 1,000 live births
Percent of population older than 65
6.6%
…projection, 2030
7.3%
Annual deaths
4.7 / 1,000 population
…caused by [highest disease burden]
N/A
…caused by [second highest]
N/A
Prevalence of [fastest growing disease burden]
Extreme Causes, Diabetes and circular system, Ischemic Heart Disease, and Lower Respiratory Infect
Sources: CIA Word Factbook, UN, Knoema
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Main Competitors
In general, the United States is the most important exporter of medical equipment to Guatemala with a significant share of the market, however there are many competing countries, and it depends on the specifications and purpose of the equipment. Germany is the second major exporter to Guatemala but is showing a decrease in almost all HS code categories due to the high prices of German brands and exporting medical equipment directly from the US is more convenient for delivery times. Japan and China are in third place, depending on the HS code, and each has different features of price and quality in their products.
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Current Demand The total number of hospitals in Guatemala is approximately 207 and the total number of clinics is 2,513. There is no accurate count for the private sector because the Ministry of Health only keeps records for the public sector.
All the hospitals will need to purchase equipment in the future, as it is a constant process in the medical field. Medical equipment such as radiology, mammography, IMR, scanners, patient monitoring systems, digital image processing clinical laboratory equipment and dialysis equipment are going to be purchased periodically by all the hospitals and clinics in Guatemala depending on necessity.
Medical equipment is constantly evolving and utilizing more sophisticated technology, and most end users are looking for new technologies as well as user-friendly features in medical devices. Also, recently end users have requested that companies provide manuals, interface labeling, and instructions for their equipment in Spanish.
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Registration Process
The Division of Registration and Control of Medicines and Foods of the Ministry of Health issues import permits for medical devices, pharmaceutical products, and cosmetics.
Some products require an inscription (registration) at the registration office of the Ministry of Health. The approximate amount of time for the registration of a medical device is between 6-10 weeks and for pharmaceuticals and cosmetics, 4-9 months. These registrations need to be renewed every five years.
The Central American Technical Regulations, CATR (RTCA in Spanish), have been recently issued for processed food products, pharmaceuticals and cosmetics, among others. The CATRs established unified standards and requirements for commercial agricultural products, pharmaceuticals, cosmetics, healthcare products, and others within the Central America and Panama region. Compliance with these technical regulations assures that products may be imported without major complications.
The CATRs require a CLV for imports of regulated products. Registrants shall present the original, signed and notarized certificate of free sale issued by the competent authority in the country of origin (in this case the U.S. Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA)).
One CLV can be issued for several products at one time. In this case, authorities accept a copy when the original CLV is filed for one of the other products in the company’s product portfolio. The CLV has a limited term, normally expiring after one or two years. When the CLV expires, registrants must replace it for the registration to remain active. In the U.S., the FDA issues Export Certificates which provide information on a product’s regulatory and marketing status. The certificate is an official assurance that products exported to other countries can be marketed in the United States and that they meet specific U.S. regulations. The FDA issues CLVs for food and beverages, dietary supplements, pharmaceuticals and cosmetic products.
For more information on these technical regulations, please visit: https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/resoluciones-comieco
[1]: https://travel.state.gov/content/travel/en/legal-considerations/judicial/authentication-of-documents/notarial-and-authentication-apostille.htmlo https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm
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Reimbursement
In Guatemala, there is no reimbursement process. Public healthcare is run by the Ministry of Health, which operates clinics in the rural areas and certain public hospitals in the larger cities. The services offered are free of charge to the population, but the services are limited due to financial constraints.
The Social Security Institute provides a variety of health benefits, including healthcare, to citizens that have a formal job and pay social security fees. Each employee has a deduction of 4.83% of their monthly salary that goes to Social Security, and the employer pays 12.67% for healthcare services for employees. Services offered by the Social Security Institute are comprehensive, but the high demand for services sometimes makes it difficult to get an appointment for days.
Private insurance companies play a significant role for the upper and middle class, as this segment of the population generally does not use Social Security due to the lack of immediate availability offered in the Social Security services - even though they also must pay the fee by law.
Private insurance companies offer different plans with monthly or annual fees, with a standard amount as a deductible; plans with lower monthly premiums have higher copayments, while plans with higher monthly premiums usually have lower copayments. Usually, the copayments are 20% by the patient and 80% by the insurance company for medicine, exams and doctor office visits.
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Barriers
There are no trade barriers for medical equipment from the U.S.
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Procurement & Tenders
Tender proceedings are public in the Republic of Guatemala. Any party or person can access any tender and follow up on its development at https://www.guatecompras.gt .
Additionally, all tenders already awarded are recorded in the above linked digital platform to improve transparency, and to make the governments’ electronic procurement system, Guatecompras, the only method of bidding on government projects, as well as to tighten bidding requirements to promote increased competition and create an electronic auction modality that requires selecting the lowest bidder for certain contracts.
The Guatemalan government must use the Guatemalan government procurement website for all healthcare purchases, and only companies registered in Guatemala can participate in the events announced on the website.
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Trade Events
In Central America, there are no fairs related to medical equipment but most importers travel once a year to the Medical equipment fair in Miami (https://www.fimeshow.com ) to meet with their counterparts and look for new products and trends.
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FAQs
1. What is the cost and time for registering products?
Processing time for a first registration may vary depending upon the product; some products take up to two months, and for others, it could take up to nine months to process the registration. The Ministry of Health provides the forms to be completed, which indicate the steps to follow for this procedure. All pharmaceuticals are treated the same, with no distinction between low- and high-risk products, with all subject to laboratory testing, and a GTQ 2,100 fee for the registration process3 (approximately $275).
Government Agreement 297-2006
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U.S. Commercial Service Contact Information
Name: Antonio Prieto antonio.prieto@trade.gov
